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NCT06716554
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
NA trial testing Shatavari extract in Menopause in 51 participants. Currently enrolling.
26 December 2024
Quick facts
| Lead sponsor | SF Research Institute, Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 26 October 2024 |
| Primary completion | 26 December 2024 |
| Estimated completion | 20 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Shatavari extract
- Shatavari + Ashwagandha extract
- Placebo
Conditions studied
- Menopause — all drugs for Menopause →
- Hot Flashes — all drugs for Hot Flashes →
- Mood — all drugs for Mood →
Sponsor
SF Research Institute, Inc.
Who can join
Adults 45 to 55, female only, with Menopause or Hot Flashes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and safety of Shatavari root extract (<i>Asparagus racemosus</i>) for menopausal symptoms: a randomized, double-blind, three-arm, placebo-controlled study.
Ademola J, Ajgaonkar A, Debnath T, Debnath K, et al · · 2025 · PMID 41394012 · DOI 10.3389/frph.2025.1654503
Verify or expand the search:
- PubMed search for NCT06716554
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Menopause
Currently open trials in the same condition.
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- NCT06975111 — Focusing on the Menopausal Transition to Improve Mid-Life Women's Health · Phase 2, PHASE3 · recruiting
- NCT07393672 — Effects of Hemp-Derived Cannabinoids on Menopause Symptoms · Phase 2 · recruiting
- NCT07412093 — The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxie · NA · active not recruiting
Other SF Research Institute, Inc. trials
Trials by the same sponsor.
- NCT07441070 — Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress · NA · enrolling by invitation
- NCT07441096 — Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women · NA · not yet recruiting
- NCT07441083 — Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness · NA · not yet recruiting
- NCT07441109 — Shatavari Root Extract for Perimenopausal Symptoms · NA · not yet recruiting
- NCT07421596 — An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06716554 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by SF Research Institute, Inc.
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06716554.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing